Lower riskMedical device recall · FDA · Published December 19, 2017
DeRoyal Sterile Surgical Kits: Prep Pads May Expire Before 36 Months
DeRoyal recalls sterile surgical kits with Medline Aplicare Povidone Iodine Prep Pads that may expire before the 36-month label date due to a manufacturing issue.
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
“DeRoyal Sterile Surgical Kits: Prep Pads May Expire Before 36 Months.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72281-deroyal-sterile-surgical-kits-prep-pads-may-expire-before-36. Based on FDA recall #Z-0334-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0334-2018%22&limit=1).
The FDA announced on 2017-12-19 that DeRoyal Industries Inc is recalling DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe. The hazard stems from Medline Aplicare Povidone Iodine Prep Pads included in the kits, which cannot support the labeled 36-month expiration date.
How to tell if you have it
Brand: DeRoyal
Product: Shoulder Arthroscopy Pack 89-8686.01, Lot 38527131
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Context
GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since 2017-06-07. Recent brand recalls include a 2026-08-20 recall for Myocardial Probe with incorrect needle size, a 2026-05-18 recall for Covaderm Plus Dressing posing a sterility risk, and a 2025-01-31 recall for Suction Tubing risking inadequate suction. Other recent recalls of similar products include Cook Medical Blue Rhino Tracheostomy Introducer Set (2026-03-05), Cook Medical Blue Rhino G2 Tracheostomy Introducer Set (2026-03-05), and Cook Medical Blue Rhino G2 Tracheostomy Tray (2026-03-05).
How to tell if you have this one
Check for DeRoyal Sterile Custom kits labeled with specific lot numbers: Shoulder Arthroscopy Packs (89-8686.01 and 89-8686.02) and Knee Arthro Packs (89-8687.01 and 89-8687.02).
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Labels
Look for lot numbers listed in the product descriptions: Shoulder Arthroscopy Packs (89-8686.01, 89-8686.02) and Knee Arthro Packs (89-8687.01, 89-8687.02).
Where it went and when
Where it was distributed
Distributed in California and Missouri.
Listed by the agency
Not listed
FDA distribution: “Distributed to states of: CA and MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Missouri.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0334-2018 (December 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0334-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.